Recall Z-1073-2013— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1073-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-11

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-03-11, terminated 2013-12-24. It names one FDA 510(k) clearance: K863594. Product: Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).. Reason: Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-11
Terminated: 2013-12-24
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K863594 — ACTIN FSL ACTIVATED PTT REAGENTAmerican Dade·cleared 1986-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).

Reason for recall

Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.

Data sourced from openFDA. This site is unofficial and independent of the FDA.